AIDS drugs off WHO list

The World Health Organization (WHO) has removed three generic HIV medicines manufactured in India from its prequalification list, which is supposed to help governments and others chose good-quality drugs to use in their public health campaigns. The three combination antiretrovirals, manufactured by Ranbaxy Laboratories, were taken off the list because a contract research organization (CRO) that had done bioequivalence studies on behalf of Ranbaxy was found to be noncompliant with good clinical and laboratory practices. "While the three Ranbaxy products to be removed from the list meet quality specifications, proof of bioequivalence is missing in view of noncompliance with good clinical and laboratory practices as well as data-handling requirements found in the contracted laboratory," WHO said in a statement. "This effectively means that the medicines may or may not offer the same therapeutic benefits as the originals on which they are based." The antiretrovirals in question are triple fixed-dose combination pills containing lamivudine, stavudine, and nevirapine in two different strengths, and a lamivudine plus zidovudine tablet. Fixed-dose combinations are cheaper and easier to take than other antiretroviral drugs and are a major part of drug access programs in the developing world. A spokeswoman for WHO told The Scientist that Ranbaxy has said it will submit the drugs for testing to another CRO. The United Nations agency is going to examine the quality standards in the new lab, she said. If they are found to be up to scratch and if bioequivalence is shown, the drugs will likely be reinstated. Ranbaxy "has already initiated work on new bioequivalence studies on these three products," the company said. "In addition, Ranbaxy is providing all necessary cooperation to WHO on its HIV franchise." Stephen Jarrett, deputy director of the supply division of the United Nations Children's Fund (UNICEF) told The Scientist the delisting of the drugs would delay some people starting on HIV therapy. "Our decision is clearly to follow WHO guidance in this area," Jarrett said. "We will stop using these drugs until they are back on the list." UNICEF is already readjusting its orders to ensure continuance of supply for patients already on antiretroviral therapy, he said. "This may delay some people starting on antiretrovirals. We do not expect the delay to be more than 3 months." This is the second time in recent months that WHO has been forced to withdraw Indian generic antiretrovirals from its list. In May, two combination antiretrovirals from Cipla were withdrawn after another CRO performing bioequivalence studies failed good clinical and laboratory practice. Cipla stressed that the move "does not mean in any way that the products are not bioequivalent. In fact, recently a bioequivalence study has been successfully conducted in the United States on Cipla's lamivudine." Also, WHO points out that it is not standard procedure for prequalification assessments to include the inspection of labs where bioequivalence studies are done, and some countries don't even require bioequivalence for the drugs they use. "The fact is that the prequalification assessments are very rigorous," the WHO spokeswoman said. In the European Union, the directive asking countries to carry out the inspection of bioequivalence labs came into force on May 1 this year. Nevertheless, WHO now plans to assess bioequivalence CROs systematically to avoid this sort of embarrassing situation in the future. Controversy over the use of generic AIDS drugs was a major talking point during the recent International AIDS Conference in Bangkok, where the US policy of only funding Food and Drug Administration–approved drugs was criticized. The United States does not recognize the WHO prequalification system. Jarrett said he thought the delisting of the drugs was a sign of the strength of the WHO prequalification system. "We believe this to be a credible and very important process," he said.

AIDS drugs off WHO list

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